Gender Relations
and Institutional Conflict
Over Mifepristone
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Jean Reith Schroedel, Claremont Graduate University
Tanya Buhler Corbin, Claremont Graduate University
ABSTRACT. This research uses mifepristone (RU 486) policymaking
under the George Herbert Walker Bush and Clinton administrations to
test whether having women in Congress and in influential positions in
the executive branch increases the likelihood that policies favorable to
women will be adopted. We consider whether women officeholders as a
group have different policy priorities than do similarly situated male officeholders, and if so, what other conditions must be met for those differences to be translated into higher levels of support for policies that women
support. The dramatic increase in the numbers of women serving in Congress and in senior policy positions in the executive branch over the past
twelve years provides us with the first opportunity to test this proposition
in both branches of government. We chose mifepristone policymaking because it was on the policy agenda throughout the period and it is an issue of
major importance to women. [Article copies available for a fee from The
Haworth Document Delivery Service: 1-800-HAWORTH. E-mail address:
<getinfo@haworthpressinc.com> Website: <http://www.HaworthPress.com>
© 2002 by The Haworth Press, Inc. All rights reserved.]
INTRODUCTION
Over the past fifteen years, feminists have made increasing the numbers of women in political office a top priority. As a result, during the
1990s there was a dramatic increase in the number of women serving in
Women & Politics, Vol. 24(3) 2002
http://www.haworthpressinc.com/store/product.asp?sku=J014
 2002 by The Haworth Press, Inc. All rights reserved.
35
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WOMEN & POLITICS
elective office. The Clinton administration included far more women in
senior staff and executive branch positions than in any previous administration. Not only did President Clinton appoint the largest numbers of
women in history to high-level executive office positions (Borelli
1997), but he was also the first president to appoint women to historically important cabinet positions. Clinton also created new institutional
channels, such as the White House Office for Women’s Initiatives and
Outreach, and the President’s Interagency Council on Women, for communicating women’s policy concerns to senior officials (Sapiro and
Canon 2000).
In light of these gains, it is imperative to re-examine the central assumption that expanding the number of women in elected and appointed office will result in more favorable policies toward women.1
For this assumption to hold up, the following conditions must be met:
(1) female officials as a group must have different policy priorities than
male officials as a group, and that these differences translate into higher
levels of support for pro-women policies, and (2) that women officeholders are able to use their greater numbers to get these policies
adopted.
PREVIOUS RESEARCH
We will begin by considering the research about women in elected
office, and then studies on women in appointed office, paying particular
attention to the overlap between both bodies of scholarship. With respect to the first condition, scholars (Carey, Niemi, and Powell 1998;
Tamerius 1997; Thomas 1994) have found that female state legislators
tend to be more liberal than comparably situated male legislators and
more likely to focus on issues of importance to women, especially reproductive policies (Berkman and O’Connor 1993; Dodson 1998;
Thomas 1994). In addition, a recent study (Reingold 2000) that showed
relatively little difference between the policy positions of male and female legislators uncovered significant gender differences in the willingness to take the lead in advocating women’s issues–the men were much
less willing to push these issues.
Sociologists (Kanter 1977, 1978; Williams 1989) discovered that
women in overwhelmingly male work environments try to minimize
their differences from the dominant group and conform to male behavioral norms. Researchers (Berkman and O’Connor 1993; Saint-Germaine
1989; Thomas 1991, 1994) found that women legislators behave in a sim-
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Jean Reith Schroedel and Tanya Buhler Corbin
37
ilar fashion. Only after women constitute a “critical mass” can they effectively promote women-friendly policies within the legislative arena.
Achieving that critical mass, however, is only the first step. Party can
be more influential than gender in determining policy preferences (Clark
1998; Dodson 1998; Dolan and Ford 1998; Schroedel and Mazumdar
1998). In her study of the House of Representatives, Norton (1997)
found that occupying institutional positions of power–committee and
sub-committee chairs and party leadership roles–are necessary if
women legislators want their policy priorities passed into law.2
Within public administration, there has been an ongoing debate over
whether public bureaucracies should be considered representative bodies
(Krislov 1974; Krislov and Rosenbloom 1981; Meier 1993a; Saltzstein
1979). Central to the concept of representative bureaucracy is the belief
that public bureaucracies should mirror the most salient demographic
characteristics of the citizenry. According to Meier (1993b), representation within a bureaucracy can be classified as either passive or active. A
passive representative bureaucracy shares demographic characteristics
with the population, but individual bureaucrats do not pro-actively push
policies that serve their needs. In contrast, an active representative bureaucracy will consciously develop policies that meet the needs of people who share their demographic characteristics.
Early studies on women in public bureaucracies focused on the numbers of women employed by local and state government agencies (Guy
and Duerst-Lahti 1992; Guy and Duke 1992; Hale and Branch 1992;
Johnson and Duerst-Lahti 1992; Kelly and Guy 1991; Kelly, Hale, and
Burgess 1991; Saltzstein 1979). Riccucci and Saidel (1997) argue that
institutional power matters; simply counting the numbers of women
within state agencies (i.e., passive representation) is inadequate because
it misses the role of women in senior appointed positions who set the
policies and provide opportunities for the active representation of
women’s interests. According to Guy and Duerst-Lahti (1992), agency
culture has a major impact on whether women can advance within public bureaucracies and whether they can actively represent women’s interests. Token women within agencies that espouse male cultural norms
find it difficult to advocate policies that are favorable to women. “Those
who ‘fit’–who manifest favored behaviors or demonstrate valued perspectives–are rewarded. Certainly such fit is crucial for promotion to
leadership positions” (Guy and Duerst-Lahti 1992, 159).
When scholars (Aberbach 2000; Bayes 1987; Borrelli 1997; Dolan
2000; Little 1994; Martin 1997; McGlen and Sarkees 1997; Sapiro and
Canon 2000; Tenpas 1997) turned their attention to the substantive im-
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WOMEN & POLITICS
pact of women appointees within the national government, they found a
severe under-representation of women and their exclusion from key institutional positions of power. Tenpas (1997) discovered in her study of
White House staff from 1939-1994 that women held only a small proportion of these positions; not usually ones that allowed them to substantively affect policy outcomes. In her comparison of the Treasury
Department and the Department of Health and Human Services, Bayes
(1987) found that the numbers of women within an agency were to
some extent a function of whether the federal agency had jurisdiction
over stereotypically “male” policies or more typically “female” ones.
Agency culture also was found to be a factor in whether women were
able to advocate pro-women policies.
One strategy for overcoming the isolation of women in male dominated work environments is through the creation of “Old Girls” networks, where women create their own networks to compensate for their
exclusion from traditional male networks (Guy and Duke 1992). While
these women-friendly networks are more likely than the traditional
male networks to assist women bureaucrats, they do not necessarily represent women’s interests more generally. Active representation, however, is facilitated by the creation of institutional linkages between
feminists within government agencies and activist women’s groups
outside of government. According to Eisenstein (1995, 81), networks
linking female bureaucrats with the broader women’s movement in
Australia have “contributed to a significant shift in public attitudes and
government priorities, and to widespread legitimization of feminist
concerns in a traditionally macho country.”
In sum, although the literature suggests that women officeholders
(both elected and appointed) as a group have different policy preferences from their male counterparts, not all women in these positions
choose to actively support policies favorable to women. Token women
often try to fit into the dominant male culture by trying to be just “one of
the boys.” Their behavior may change when the number of women becomes sufficiently large as to constitute a “critical mass.” Increasing the
numbers of women does not necessarily culminate in active representation of women’s interests; it may simply result in passive representation. More women officeholders, whose ideology or partisan affiliation
are hostile to feminism, will not lead to the adoption of pro-women policies. Finally, women in elected and appointed office have a greater
chance of getting policies adopted if they occupy institutional positions
of power.
Jean Reith Schroedel and Tanya Buhler Corbin
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MIFEPRISTONE POLICY-MAKING AS A CASE STUDY
Case study research is typically used to explain events–“how” or
“why” something occured (Yin 1989). Single case studies often are
used when doing exploratory research, particularly when the phenomenon is new or had previously been inaccessible to researchers (Yin
1989). RU 4863 policy-making constitutes just such a single case study
because it provides one of the first opportunities to study whether the
numbers of women in both Congress and the executive branch must
constitute a critical mass to get feminist policies adopted. We also consider other mitigating factors that may facilitate or impede the adoption
of such policies, which raises the possibility that a critical mass is necessary but not sufficient by itself. Because reproductive policies are particularly important to women legislators, RU 486 policy-making is an
appropriate case for studying the impact of women officeholders. Since
the approval process involved Congress, the White House, and the
FDA, we can study women’s influence in different institutional settings
and under different partisan configurations. Because the number of
women officeholders (both elected and appointed) changed dramatically
over the time period, we are able to assess whether the relative proportion
of women in office affects their ability to get women-friendly policies
adopted.
We propose that: (1) greater numbers of women in Congress and the executive branch resulted in different policy outcomes in the mifepristone approval process; (2) women in institutional positions of power helped
place mifepristone on the policy agenda and move it through to approval; (3) party and ideology also exert strong influence on women officeholders; and (4) divided government makes it far more difficult for
an administration to pursue its policy aims. We compare the George
Bush and Clinton administrations, paying particular attention to the differences in the FDA and Congress during both time periods. As is often
the case, one cannot assess the impact of women without also examining the actions of male officeholders. Since women typically are viewed
as having more legitimacy than men when it comes to discussing reproductive policies, we also examine the strategies used by male officeholders to offset women’s gender advantage.
We utilized a range of different types of data gathering methodologies. Primary source materials include congressional committee hearings, House and Senate floor debates, and FDA documents. Much of
our assessment is based on elite interviews conducted with congressional and caucus staffers, legislators, lobbyists, and other key actors.4 Al-
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WOMEN & POLITICS
though the same topics were covered in each of the interviews, the
wording of questions varied somewhat because the interviewees were
active in different policy making arenas. Because the aim was to elicit
“insider” accounts of behind the scenes events, open ended questions
rather than a more rigid format were used.5
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THE BUSH ADMINISTRATION AND MIFEPRISTONE
In early 1989, George Bush asked the FDA to issue an import alert, stating that mifepristone posed potential health risks to women and banning
the import of the drug even for personal use. Senator Jesse Helms (R-NC)
and Representative Henry Hyde (R-IL) also urged the FDA to ban the
drug. Shortly thereafter, FDA Commissioner David Kessler issued an import ban on mifepristone. The ban was a signal to the manufacturer Roussel
Uclaf that the political climate in the United States was hostile to RU 486
(Jackman 1997). The appointment of the first woman to head the National
Institutes of Health (NIH) in 1991 did not lead to a re-evaluation of the policy. Dr. Bernadine Healy opposed all RU 486 research (Schroeder 1998).6
Healy, a conservative Republican with ties to former White House Chief of
Staff Sununu, felt that the NIH must be sensitive to political considerations,
not solely scientific ones (Browning 1991).
During the early Bush years, the women in Congress did not constitute a critical mass capable of moving issues onto the policymaking
agenda. Usually a numerical minority must comprise roughly 15% percent of a group to be able to represent its group interests effectively
within the larger body (Kanter 1977, 1978). In 1989, there were only 25
women in the House and two in the Senate (5% of the membership of
the two chambers). Four years later, that proportion rose to only 6% of
each chamber and many were Republicans, who probably felt pressure
from the party not to publicly oppose a policy initiated by a Republican
president. None occupied institutional or party leadership positions.
Some supporters of mifepristone sought to overcome their own individual lack of power by getting the Congressional Caucus on Women’s Issues
to endorse ending the ban. At the urging of the Caucus Chair, Representative Patricia Schroeder (D-CO), members sent letters to the president and
the FDA urging them to reconsider the import alert (Schroeder interview
2000). Caucus members also asked President Bush to meet with them, but
he refused to do so throughout his entire term in office (Schroeder 1998).
Although the Democratic Party was more responsive to women’s issues than was the Republican Party, neither gave them much consider-
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Jean Reith Schroedel and Tanya Buhler Corbin
41
ation. Republican women comprised 5.4% to 6.3% of their party’s
membership in the House and 2.2% in the Senate during the Bush
years (1989-1992). Women comprised from 5.4% to 7.1% of House
Democrats and 1.8% of the party within the Senate. Although the
women’s representation in both parties fell far short of constituting the
15% needed to be considered a “critical mass,” the Democrats were
slightly more responsive to the women than the Republicans. Democratic Party leaders met regularly with members of the Caucus on
Women’s Issues.
This access did not translate into Democratic leaders choosing to
push for a removal of the import ban, although a handful of male members agreed to work toward legalizing RU 486. Representative Ron
Wyden (D-OR), chair of the Subcommittee on Regulation, Business
Opportunities, and Energy (Committee on Small Business) held hearings on the import ban in 1990 and subsequently introduced a bill,
H.R. 875, to remove the import ban. The bill was referred to the Committee on Energy and Commerce, where it died. Senator Alan Cranston
(D-CA) introduced a companion bill (S. 2268), but it died in the Committee on Labor and Human Resources. Suspecting that the import alert
was politically motivated, Representative Ted Weiss (D-NY) asked
the FDA for a formal explanation of its findings (Charo 1991).7
Representative Wyden held hearings again in 1992. Scientists, a
brain tumor patient, actress Cybill Shepard, and several pro-choice
groups testified that the import ban hindered research on non-abortion
applications of the drug. Wyden concluded that: “RU 486 has now been
effectively blocked for all uses in this country because one use does not
pass the Administration’s anti-abortion political litmus test” (U.S.
House, Subcommittee on Regulations, Business Opportunities, and Energy, Committee on Small Business 1990, 1).
In July 1992, Abortion Rights Mobilization (ARM) recruited a
pregnant woman, Leona Benten, to travel to Europe and purchase RU
486 for personal use (Lader 1995). When she returned to the U.S., customs officials confiscated the drug. In Benten v. Kessler (1992), a U.S.
District Court judge ruled that the FDA ban was politically motivated,
but the U.S. Second Circuit Court of Appeals blocked the decision.
Representative Schroeder introduced a bill (H.R. 5635) to have the
FDA return Leona Benten’s pills, but it died in committee.
The Bush administration blocked every effort to change mifepristone
policy. The only woman in a position to influence their policy was NIH
Director Healy, but she supported the ban. Women in Congress had few
opportunities to get the issue on the policymaking agenda. Attempts to
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overcome their numerical disparity by using the Congressional Caucus on
Women’s Issues failed. In the House, there were no women on the committees that might have considered legislation dealing with mifepristone, and
male Democratic Party leaders did not consider it an issue worth pursuing. In the Senate, the two women on the Committee on Labor and Human Resources failed to mobilize support for considering the Cranston
bill. Given the paucity of women and their lack of position power, it is
not surprising that their efforts were ineffective.
THE CHANGING OF THE GUARD:
THE CLINTON ADMINISTRATION
The situation changed dramatically after the 1992 election. Feminist organizations, which had strongly supported Clinton’s campaign, expected
him to be responsive to their concerns, and they were not disappointed. The
bipartisan Coalition for Women’s Appointments, an umbrella group representing women’s organizations and prominent feminists, lobbied
Clinton to increase the numbers of women appointed to policymaking
positions within the executive branch and provided him with lists of potential appointees. Feminist groups also asked him to use the powers of
the presidency to place their issues on the policymaking agenda. According to the Feminist Majority Foundation (Jackman interview
2000), getting RU 486 approved for use in the United States was raised
by representatives of women’s groups in early meetings with the president and his advisors.
In January 1993, Clinton directed Secretary of Health and Human
Services Donna Shalala to have the FDA re-evaluate the import alert
and assess ways to promote mifepristone approval (Clinton 1993). FDA
Commissioner David Kessler, who issued the import ban in 1989, reversed his position and began negotiations with Roussel Uclaf to bring
the drug into the country (Corfman interview 2000).8 Pro-choice groups
began lobbying Congress to remove Roussel Uclaf’s patent based on a
law that permits removal on products not being marketed in the United
States. Secretary Shalala personally played a major role in getting the
relevant parties to negotiate (Jackman interview 2000). After ten
months of discussions, Shalala set a May 15, 1994 deadline for the parties to reach an agreement and on the following day Roussel Uclaf
signed over patent rights to the Population Council.
Jean Reith Schroedel and Tanya Buhler Corbin
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THE FOOD AND DRUG ADMINISTRATION HEARINGS
Before any new drug or medical device can be approved for marketing in the United States, FDA approved clinical trials showing the product’s safety and efficacy must be conducted.9 The sponsor of the drug
submits an application to the FDA requesting permission to hold clinical trials. To gain approval for clinical trials, the sponsor must present
clinical data from tests on animals showing that the drug is not likely to
have safety problems (Institute of Medicine 1992). The typical drug undergoes three phases of clinical trials. On the average it takes 12 years
for a drug to move through the FDA mandated steps to approval
(Burkholz 1994).
The FDA under Clinton moved the consideration of mifepristone
onto the fast track. Clinical trials started in 1994, only five months after
patent rights were transferred to the Population Council. Consideration
of RU 486 was given to the Advisory Committee for Reproductive
Health Drugs,10 which is responsible for ensuring that drugs meet the
mandated safety and efficacy standards. All eight members of the Committee (five women and three men) have extensive research and clinical
experience in the area of reproductive health; six were physicians.
The Population Council submitted a New Drug Application to the
FDA in March 1996. Dr. Ezra C. Davidson, chair of the Advisory Committee for Reproductive Health Drugs, moved quickly, scheduling July
hearings on the safety and efficacy of mifepristone and misoprostol
when used to terminate an early pregnancy. Two-thirds of the 33 people
who testified favored approval. The gender breakdown and the substance of the arguments presented by the two sides were quite different.
Eighteen of the 22 people testifying in favor were women. Favorable
testimony was provided by representatives of many women’s groups
and prominent health organizations, including the Feminist Majority
Foundation, American Medical Students Association, American Public
Health Association, National Women’s Health Network, American
College of Obstetricians and Gynecologists, and the National Organization for Women. The proponents presented medical evidence showing
that the drug was a safe and effective means of terminating an early
pregnancy. They also stressed that approving RU 486 would restore a
patient’s dignity, safety, and privacy rights by allowing her to end pregnancies without being harassed by abortion clinic protesters. Four physicians and eight public health professionals testified in favor of
approval.
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WOMEN & POLITICS
Of the five men and six women who testified against approval, eight
were representatives of right-to-life groups, including the Family Research Council, Life Issues Institute, and Pharmacists for Life International. All argued that the drug was unsafe to women and “unborn
babies.” Four physicians stated that patients might not go in for their
follow-up visits, causing complications in cases where the fetus was not
fully expelled. The opponents spent a substantial amount of time discussing their medical credentials (U.S. Food and Drug Administration
1996)–possibly as a means of enhancing their credibility.
After considering the testimony, seven members of the Committee
voted that the drug was safe. The final member, Dr. Mary Jo O’Sullivan,
abstained because she deemed RU 486 harmful to the fetus. Dr.
O’Sullivan’s decision to abstain was driven by her strong religious beliefs; as a Catholic, she could not morally vote to approve a drug that
would harm fetal life. However, she was able to concur on the finding
that RU 486 did not pose a threat to women’s health. This interpretation
was corroborated in personal correspondence with Dr. O’Sullivan, who
wrote, “As for my abstention, I do not believe that abortion is indicated
for ANY reason” (O’Sullivan 2001).
The Committee voted six to two that the drug was efficacious. Dr.
Cassandra Henderson and Dr. O’Sullivan voted no because they wanted
to see the final U.S. trial data before approving it (U.S. Food and Drug
Administration 1996). The FDA issued an approvable letter in September, stating that the drug was safe and effective, but that manufacturing
and labeling information was needed before they would issue a final approval (Population Council 2000).11
CONGRESSIONAL EFFORTS TO DERAIL MIFEPRISTONE
Representative Tom Coburn, a physician with strong right to life credentials, has been the clear leader of the anti-mifipristone forces within
Congress. Coburn used a wide range of tactics to try and halt approval.
He submitted testimony to the 1996 FDA hearings, citing health and
safety risks to women as his primary objection to the drug.12 Coburn
sent “Dear Colleague” letters opposing the drug to other members of the
House and op-ed pieces to newspapers. He used mass e-mails to keep
other anti-abortion legislators informed. Because of his medical credentials, other representatives considered Coburn a credible source of information about mifepristone (Schwartz interview 2000). Coburn and
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45
his staff worked closely with anti-abortion interest groups in developing strategies to halt approval (Schwartz interview 2000).
One of the strongest ways that members of Congress can signal dissatisfaction with the actions of an independent regulatory agency is
through the appropriations process (Meier 1985). Even though he was
not on the Appropriations Committee, Coburn sponsored agricultural
appropriations amendments in 1998, 1999, and 2000 that would bar the
FDA from using federal money to test mifepristone. His 1998 amendment (H. Amdt. 705) to the Agriculture FY99 Appropriations Bill prohibited any funds from being used by the FDA for the “testing,
development, or approval (including approval of production, manufacturing, or distribution) of any drug for the chemical inducement of abortion” (Coburn 1998). The House passed the amendment by a 223-202
vote, but it was dropped in conference committee. In 1999, Coburn offered the same amendment (renamed as H. Amdt. 142) to the Agriculture
FY2000 Appropriations Bill. On June 8, the House voted 217-214 to
adopt the amendment, but again it was removed from the final legislation
by the conference committee. His third attempt to pass the amendment
(renamed as H. Amdt. 6) on July 10, 2000 failed in the House, a result
which staffers attributed to low attendance because it was election season
(Folking interview 2000; Schwartz interview 2000). The vote was 182 in
favor versus 187 against with 65 members not voting.
The voting on the amendments provides insights into the ways that
gender and party affect legislative decisions. In 1998, 214 out of 366
male representatives (58.5%) voted in favor of the amendment, but only
9 out of 52 (17.3%) female representatives also cast votes in favor of it.
In 1999 the gender breakdown was very similar, with 210 out of 374
men (56.1%) voting in favor and only 7 women out of 58 (12.1%) doing
the same. Despite the high level of non-voting in 2000, the gender
breakdown was comparable. Of the 325 male representatives who
voted, 176 (54.2%) voted yea as compared to only 6 of the 44 (13.6%)
female representatives.
Party affiliation is strongly related to the voting. In 1998, 83.6% of
Republicans voted in favor, but only 17.6% of Democrats. Similar
breakdowns occurred in 1999 and 2000, when 81.9% and 81.4% of Republicans voted yea. Among Democrats only 17.2% cast votes in favor
in 1999 and 17.4% did the same in 2000. What initially appears to be
straight party line voting disappears, however, when gender and party
are jointly analyzed. Republican women were almost equally divided
between supporters and opponents of the amendments–nine in favor
and seven against in 1998, seven in favor and nine against in 1999, and
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WOMEN & POLITICS
six in favor and seven against in 2000. Not a single Democratic woman
voted in favor of any of the amendments.
Although Coburn was easily the most vocal opponent within the House,
two other Republicans–Representative Chris Smith (NJ), co-chair of the
Pro-life Caucus and former Americans United for Life board member, and
Representative Dave Weldon (FL)–were active. Most of the day-to-day activities were handled by congressional staffers. The Values Action Team
(VAT), an informal House group of about 15 right to life staffers, developed strategies and coordinated efforts to stop approval. These included
writing letters to the president and the FDA, circulating “Dear Colleague”
letters, drafting legislation, and preparing talking points for use in the floor
debates. The VAT collaborated with groups such as: the Family Research
Council, Eagle Forum, National Right to Life Committee, Christian Coalition, Concerned Women for America, and the Traditional Values Coalition (Udovich interview 2000).
Although most of the congressional action occurred in the House, a
few senators spoke against approval on the Senate floor. Senator Tim Hutchinson also wrote letters to the FDA and spoke against mifepristone in
floor debates.13 He also worked with Representative Coburn and Senator Nickles, the majority whip, on coordinating Senate and House efforts (Bennett interview 2000). Although not as well organized as VAT
in the House, a group of Senate staffers met regularly to develop strategies to halt the approval (Bennett interview 2000).
All of the leading congressional opponents of mifepristone were male.
Although Representatives Helen Chenowith (R-ID), Sue Myrick (R-NC),
and Anne Northrup (R-KY) opposed approval, they were far less active
than their male colleagues. The lack of unified opposition among Republican women was mentioned by staffers as one of their greatest weaknesses. One said that if they had all of the Republican women on their
side they could pass anything and everything (related to abortion). Several staff noted that a major strength of the pro-choice side is that most of
the women in Congress support reproductive rights. They also felt that
women have more credibility than men to speak on reproductive issues
(Bennett interview 2000; Schwartz interview 2000).
WOMEN LEGISLATORS PROVIDE KEY SUPPORT
FOR MIFEPRISTONE
Even though Congress is still overwhelmingly male, the numbers of
women increased dramatically after the 1992 elections. In the 102nd
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Congress (1991-1992) there were only 28 female representatives and
two senators, but in the 103rd Congress (1993-1994), there were 48
women in the House and six in the Senate. Although still a numerical
minority from 1993 onwards, women constituted a growing and critical
mass (more than 15%) within the Democratic Party. As such, party
leaders could no longer safely ignore the concerns of women members.
During the Clinton years, women were the strongest supporters of
mifepristone in Congress. They chose a low profile strategy, arguing
that “science, not politics” should determine the outcome (Coleman interview 2000; Reid interview 2000). As Representative Carolyn
Maloney (D-NY) said, “We are legislators, not scientists. Political mandates have no place in interfering with the FDA’s sound and rigorous
scientific drug approval process” (Congressional Record 1999). Representatives Nita Lowey (D-NY), Sheila Jackson Lee (D-TX), Rosa
DeLauro (D-CT), and Lynn Woolsey (D-CA) also made pro-mifepristone
statements on the floor. Representative Louise Slaughter (D-NY) wrote a
letter to the FDA that was signed by 36 other members, expressing concern about delays in the approval process (Reid interview 2000). She
met with Secretary Shalala’s office about the delays, circulated “Dear
Colleague” letters, and kept other members abreast of developments
(Reid interview 2000). Senator Barbara Boxer (D-CA) sent letters to the
FDA urging approval and worked with other women senators including
Patty Murray (D-WA) and Olympia Snowe (R-ME) to mobilize support. Moreover, the women senators often meet informally to discuss
women’s issues and strategies (Lewis interview 2000).
One of the most significant differences between the Bush and
Clinton years was that the pro-choice women in the House had moved
into positions of institutional power. Lowey, Woolsey, and DeLauro
were on the Appropriations Committee. Slaughter was on the Rules
Committee. DeLauro was also the Chief Deputy Minority Whip, an important Democratic Party position. Two mitigating factors were the
women’s mid to low seniority on these committees and the Republican
take-over of Congress after the 1994 election.
By choosing a hands-off strategy of science over politicization, advocates of mifepristone legalization gave the appearance of doing less
than their opponents. They did, however, exploit their credibility as
women to speak out in favor of mifepristone. As the legislative director
for Nita Lowey said, “Since the issue is about women, they have a more
commanding moral voice on the issue” (Coleman interview 2000).14
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THE FOOD AND DRUG ADMINISTRATION
IN THE LATER YEARS:
1998-2000
After the FDA issued the approvable letter in 1996, many thought
that mifepristone would soon be available, but the process stalled because the Population Council could not find a manufacturer. Implied
and overt threats of violence and boycotts by anti-abortion groups
scared pharmaceutical companies away from the drug (Jackman interview 2000). After FDA Commissioner David Kessler resigned in 1998,
the question of finding a manufacturer came up in hearings over
whether Clinton’s nominee, Dr. Jane Henney, would gain Senate approval.
Senator Nickles voiced his opposition to efforts to find a manufacturer: “At a time when the agency was struggling to approve drugs which
cure diseases and save lives, the Agency was focusing . . . on a political
agenda which would end the life of an unborn child. I am offended by
that” (Senate Labor and Human Resources Committee 1998). Dr.
Henney stated that she believed “the Agency should only solicit product
applications in extraordinary circumstances in which there is a clear public health need. If I am confirmed as Commissioner I would not solicit a
manufacturer for RU 486” (Henney 1998). When asked by Senator Michael Enzi (R-WY) about the safety of the drug “with respect to the baby
carried by the individual taking it,” Dr. Henney said that she understood
the role of the FDA was to review the drug’s safety and efficacy based on
the intended use, which in the case of mifepristone, is to terminate a pregnancy (Senate Labor and Human Resources Committee 1998).
Satisfied that Dr. Henney would not push to find a manufacturer, the
senators decided to support her nomination and she was easily confirmed. As head of the FDA, Dr. Henney did not pursue a manufacturer,
which would have been a highly unusual role for the FDA to take in
most drug approval cases. Her own public position was akin to that of
the pro-choice women members of Congress–that science, not politics
should determine policy. In an interview with MSNBC the day the FDA
approved mifepristone, Dr. Henney reiterated her commitment to science seven times. When asked about her personal views on abortion,
she said: “As commissioner, what I’m expected to do is see that products are reviewed in an objective and scientific fashion and my personal
views are not really to play in those decisions.” She also noted that the
FDA bases their decisions in science, and that the agency is objective in
its decision-making (MSNBC 2000).
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49
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THE FDA’S FINAL APPROVAL AND BEYOND
In February 2000, the FDA issued a second approvable letter, but indicated it was considering a host of restrictions on RU 486 such as requiring physicians to be listed on a national registry, distribution and
use limited to licensed physicians, limiting prescription rights to doctors who perform surgical abortions, requiring physicians to use ultrasound to date the pregnancy, FDA training certification, long-term
tracking studies of patients, and only allowing doctors with hospital admitting privileges to prescribe it. The American College of Obstetricians and Gynecologists argued that the restrictions placed unnecessary
burdens on physicians and patients (American College of Obstetricians
and Gynecologists 2000). Right to life members of Congress lauded the
restrictions, arguing they were needed to protect women’s health and
safety.15 Proponents labeled the restrictions as unnecessarily restrictive.16
On September 28, 2000, the FDA issued final approval with only a
few restrictions. Distribution had to be handled by physicians who
could accurately determine the length of a pregnancy and had made provisions for back-up surgical abortions if necessary (U.S. Department of
Health and Human Services 2000). Gaining FDA approval had taken
twelve years.
Opponents claimed that an expedited approval process had ignored
safety concerns (O’Bannon interview 2000). Representative Coburn’s
administrative director described the FDA’s approval as a personal betrayal by Dr. Henney, who he believed had reneged on her commitment
not to pursue a manufacturer (Schwartz interview 2000). Former FDA
scientist Dr. Philip Corfman notes that Dr. Henney did not promise that
she would not approve the drug, only that she would not advocate for it.
He further argued that any potential appointee would likely have taken
an equally politically strategic stance (Corfman interview 2000).
Concerned Women for America (CWA), a conservative women’s interest group, held a press conference on September 28 (Concerned
Women for America 2000). Several conservative legislators issued
statements denouncing the approval at the press conference. Representative Chris Smith stated, “RU 486 is baby poison–it is baby pesticide . . .
it is potential poison for the mothers who take it” (Smith 2000). Representative Dave Weldon (R-FL) said the approval was a “grave mistake”
(Weldon 2000). Senator Tim Hutchinson called for the Health, Education, Labor and Pensions Committee to hold hearings about the FDA’s
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approval process (Hutchinson 2000). Sue Myrick (R-NC) and Helen
Chenowith-Hage (R-ID) also condemned the FDA’s decision.
Congressional opponents and right to life groups launched a drive to
reverse the FDA’s approval (Bennett 2000). Representative Coburn and
Senator Tim Hutchinson immediately introduced bills (H.R. 1535; S.
3157) that would impose all of the restrictions that the FDA rejected.
The bills died in their committees, probably because it was the end of
the session. Anti-abortion groups launched a media campaign to expose
what they believe are grave health risks to the woman and the unborn
child (Udovich 2000). Legal challenges to the approval are also being
considered because the manufacturer of misoprostol only approved it to
treat gastric ulcers, not for labor induction or abortion (Schwartz 2000;
Searle 2000).17
ACTIONS OF THE NEW BUSH ADMINISTRATION
Congressional staffers on both sides of the issue believe that President George W. Bush will try to undermine the FDA’s ruling. At the
time of the FDA approval, candidate Bush stated, “I think the FDA’s
decision to approve the abortion pill is wrong. . . . As president, I will
work to build a culture that respects life” (Bush 2000). He also pledged
to look for new evidence that the FDA should revisit its decision (Zitner
2000). Bush nominated (and the Senate narrowly confirmed) a staunch
abortion opponent, John Ashcroft,18 to be the Attorney General. Former
Wisconsin Governor Tommy G. Thompson, also a strong abortion opponent, replaced Donna Shalala as Secretary of Health and Human Services. According to some sources, Thompson has already promised to
order a review of the FDA’s approval (Benshoof 2001). Despite strong
support from medical groups and the health industry, FDA Commissioner Henney was almost immediately terminated. Many commentators believe that her removal was politically motivated and due to the
FDA’s approval of mifepristone (Cimons 2001; Jackman 2001).
President Bush’s early actions indicate that he is unlikely to respond
favorably to issues raised by women’s groups. He eliminated the White
House Office for Women’s Initiatives and Outreach that Clinton created
to assure that women’s issues received attention at the highest levels of
government (“Candidates” 2000). Even the passive representation of
women has declined. According to Brookings Institution figures, the
Bush administration’s early record on appointing women to senior policy positions is substantially weaker than that of the Clinton administra-
Jean Reith Schroedel and Tanya Buhler Corbin
51
tion at the same time. Only 26% of Bush’s appointees are women, as
opposed to 37% of the early Clinton administration appointees (Tessier
2001). When asked about Bush appointees, Rosalyn O’Connell, the Republican president of the bipartisan National Women’s Political Caucus
said, “I’m discouraged for women generally because it’s a signal that
we’re just not important” (Tessier 2001).
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CONCLUSION
The mifepristone approval process illustrates the complicated nature
of policymaking. It also demonstrates the need to have women in political office. Although women in both the House and the Senate overwhelmingly favored approval, it was only after their numbers had grown
sufficiently large as to constitute a critical mass, at least within the Democratic Party, that the women could rally support from party leaders. The
effects of gender, party, and ideology were clearly evident in Congress.
All of the leading opponents were Republican men. In their voting on
the anti-mifepristone Coburn amendments, Republican women were
evenly divided, but Democratic women were united in their opposition.
As Democratic women in Congress gained seniority, position power,
and numbers, they felt more comfortable taking a leading and public
role in the campaign for approval. The “science, not politics” mantra allowed them to distance themselves from partisan and ideological considerations. At the same time, they were able to tap into feminist
sentiment by making statements about women’s right to privacy and
control over one’s body, and freedom from harassment at abortion clinics. The opponents had to find other means to gain credibility, most notably by using physicians to speak against mifepristone. They tried to
undercut the gender-based credibility of proponents by continually
stressing concerns about the safety of women taking mifepristone.
This research also strongly suggests that feminists need to focus as
much on getting women into appointed office as on elective office because much of the impetus in policymaking occurs within the executive
branch. But again, it is important to remember that not all women are
feminists. Female appointees in Republican administrations are not
likely to advocate feminist policies. Unlike Republican women elected
officials, who occasionally can deviate from party orthodoxy when it
runs counter to the preferences of their constituents, women in appointed executive branch positions serve at the pleasure of the president. Given the strong anti-abortion stance of the Republican Party, a
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WOMEN & POLITICS
Republican president is not likely to tolerate dissent among appointed
officials. In fact, strong anti-abortion credentials appear to be a requirement of all recent Republican appointees with policy making power
over reproductive rights.
This study highlights the importance of the presidency in policy-making. The first Bush administration was able to easily prevent
mifepristone from being made available in the U.S., while strong backing
from Clinton was key in gaining subsequent FDA approval. Mifepristone
approval was part of the Clinton agenda from the very beginning.
Shortly after his election, Clinton met with the bipartisan Coalition for
Women’s Appointments and assured them that women and their interests would be represented in his administration. Although two female
Clinton appointees, Health and Human Services Secretary Shalala and
FDA Director Henney, were instrumental in moving the process forward, it is impossible to determine how much of their advocacy can be
explained on the basis of biological sex and how much is due to the
president’s stance. Most likely, a congruence exists between their own
ideology, gender, and Clinton’s preferences–which was a major reason
why they were appointed. The reversal in stance, however, by FDA
Commissioner Kessler is clearly attributable to a change in presidential
administrations. In a similar vein, most observers believe that the new
Bush administration will find ways to impede women’s access to the
drug.
Finally, this study illustrates the difference between passive and active representation of women in the bureaucracy. Even though the first
Bush administration had more than twice as many senior women in policy-making positions than its predecessor, the women did not actively
represent women’s interests in the area of reproductive rights. In fact,
the only senior female appointee with position power over reproductive
policies, NIH Director Healy, was an active opponent of mifepristone.
The stance of the women within the Clinton administration was diametrically opposed to that of the Bush appointees. Health and Human Services Secretary Shalala clearly was an active proponent of approval and
went to extraordinary lengths to keep it from being derailed. FDA Director Henney refused to bow to pressure from congressional opponents
and followed the recommendations put forth by the Advisory Committee for Reproductive Health Drugs. More broadly, President Clinton
created new institutional channels to ensure that women’s policy concerns would get attention at the highest levels of his administration–all
of which have been abolished by George W. Bush.
Jean Reith Schroedel and Tanya Buhler Corbin
53
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NOTES
1. Defining “women’s issues” is difficult because it is subjective. For our purposes, we use the definition offered by Tamerius, where feminist legislative initiatives
“ . . . promote the well-being of women through one or more of the following: eliminating discrimination on the basis of sex, redressing grievances of women who have suffered discrimination on the basis of sex, addressing needs arising from women’s
unique physiologies or socioeconomic conditions, or achieving public recognition of
women’s contributions to society” (1997, 105).
2. See also Kathlene’s (1998) research on how women legislators who have position power (i.e., occupying committee and sub-committee chair positions) are often
challenged by lower ranking male legislators.
3. Mifepristone is the scientific name for the drug; RU 486 is the name first assigned by the French manufacturer Roussel Uclaf.
4. A two stage process was used to determine the choice of interview subjects. We
began by reading secondary source materials and transcripts of congressional hearings
and testimony to identify which interest groups and members of Congress appeared to
be major players in the debate over mifepristone. The first group of interviewees was
drawn from this group. A modified “snowball” technique was used to augment the initial list (i.e., each interview subject was asked to identify other key actors). Although
some people refused to participate, we believe that we succeeded in getting a broad
cross section of participants. Particular effort was taken to ensure that the views of both
proponents and opponents of the drug were fairly represented in the pool of interviewees. A list of interviewees is available from the authors.
5. For a summary of the techniques used in elite interviews, see Johnson and
Joslyn (1995). See also Williamson, Karp, and Dalphin (1977) for a discussion of intensive interviewing techniques, the ordering of questions, and follow-up probes.
6. The NIH position was not Healy’s first executive branch appointment. President Reagan had appointed Healy in 1984 to serve as deputy director of the White
House Office of Science and Technology Policy. In 1990 she was appointed to the
President’s Council of Advisors on Science and Technology. According to Browning
(1991, 2603), critics believe that Healy was appointed as the first female head of the
NIH because the administration “expected her to toe the line politically.”
7. Congressional oversight of independent regulatory agencies, such as the Food
and Drug Administration, occurs within the authorizing committees and the appropriations committees. Members seeking to influence regulatory behavior have a variety of
means for doing so: hearings, informal contacts, revising the agency’s mandate, and
cutting the budget (Meier 1985).
8. FDA Commissioner Kessler’s initial opposition to mifepristone and subsequent
support of the drug can only be explained by changes in the political context. Medical and
scientific research showing that mifepristone was a safe and effective means of terminating
an early pregnancy was widely available during the Bush years. According to Burkholz
(1994), Commissioner Kessler twice canceled prepared congressional testimony after the
White House signaled that his positions contradicted those of the president. In describing
Kessler, Burkholz (1994, 184) writes, “But if the new commissioner was not a politician in
the party sense, he had highly developed political skills in the art of the possible, and during the Bush years he used those skills whenever he had to.”
9. The 1906 Food and Drug Act gave the power to regulate food and drugs to ensure the public’s safety to the Food and Drug Administration, but did not give the
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WOMEN & POLITICS
agency authority to ascertain whether drugs were safe prior to their being marketed,
only the power to ask a court to withdraw unsafe products from the market. The 1938
Food, Drug and Cosmetic Act expanded their authority to include pre-market approval
of food, drugs, medical devices, and cosmetics to ensure the safety of consumers. For a
short history of the FDA, see chapter 4 in Johnson (1992).
10. Within the FDA, agency-chartered advisory committees, comprised of leading
experts in the field, have been used for nearly four decades. In 1962, shortly after the
thalidomide crisis, Congress unanimously passed amendments to the Food, Drug, and
Cosmetic Act to require that the FDA assess the efficacy, as well as the safety of all
drugs on the market. At that time, there were more than 4,000 prescription drugs that
had been approved as safe by the FDA; all of which would then have to undergo testing
for efficacy. The FDA did not have enough in-house experts to do the testing and
turned to the National Academy of Sciences-National Research Council for assistance.
This evolved into the current system of advisory committees comprised of scientists
and physicians (Institute of Medicine 1992).
11. The FDA issues approvable letters when the safety and efficacy of a drug has
been verified, but there are still questions that must be resolved before it can be marketed.
An approvable letter does not give a company permission to begin marketing the drug.
12. In 1995, Coburn and 22 other members filed a citizen’s petition with the FDA
urging them not to approve the drug because many patients would not return for follow-up visits, which could endanger their health (Citizen’s Petition 1995).
13. Senator Tim Hutchinson is an ordained Southern Baptist minister and a graduate of Bob Jones University. He is a member of the Labor and Human Resources Committee that has jurisdiction over reproductive policies.
14. The Congressional Caucus on Women’s Issues requires unanimous agreement
on an issue prior to taking a position (Hammond 1998). This led to a decision to stay
neutral on “choice issues” in order to keep the caucus bipartisan (Women’s Congressional Caucus 2000).
15. For a complete discussion of the opponents’ arguments in favor of the restrictions, see “Press Conference on RU-486 with Senator Tim Hutchinson (R-AR) and
Representative Tom Coburn (R-OK), 10/04/00.” Text from: Federal News Service,
Inc. Available from: Congressional Universe (Online Service). Bethesda, MD: Congressional Information Service.
16. For a complete discussion of the proponents’ arguments, see the Feminist Majority Foundation’s website at: http://www.feminist.org/ru486.
17. Several pro-life groups are organizing state level challenges to the regimen
(Claiborne 2000). See, for example, the recent Michigan challenge where opponents
are attempting to halt the use of misoprostol (Simon 2001).
18. In his six years in the Senate (1995-2000), Ashcroft (R-MO) compiled a perfect
100% support score from the Christian Coalition.
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